EUCTR2017-002674-39-IT进行中（未招募）1 期
An Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated with ACH-0144471 - N/A
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must have completed the C3G Proof of Mechanism (POM) study (ACH471-201) (participation in the long-term follow-up portion of ACH471-201 is not required), OR must meet all the following criteria:
- •a. Must have confirmed primary C3G or IC-MPGN as per the following:
- •- Initial diagnosis established at least 3 months prior to the first dose of study drug
- •- Initial diagnosis prior to the age of 55
- •- Not secondary to another underlying condition in the opinion of the PI
- •b. Must have confirmation of C3G or IC-MPGN diagnosis with at least 2+ staining for C3c by review of a renal biopsy obtained no more than 30 days (and preferably within 2 weeks) of first dose of study drug by the study’s central pathology laboratory
- •c. Must have clinical evidence of ongoing disease based on at least one of the following findings attributable to C3G disease or IC-MPGN in the opinion of the PI, and present prior to study entry and confirmed during Screening:
- •- Significant proteinuria, defined as =1 g/day of protein in a 24-hour urine
- •- An abnormal eGFR, defined as <=75 mL/min/1.73 m2 (based on CKD-EPI creatinine equation [2009] for patients 19 years old and older, or on Bedside Schwartz” equation [2009] for patients <19 years old). The abnormal eGFR should not be attributable to non-C3G causes such as angiotensin converting enzyme (ACE) inhibitor use or decreased renal perfusion, in the opinion of the PI
- •d. Must have no more than 50% fibrosis and no more than 50% of glomeruli with cellular crescents on the pre-treatment renal biopsy
- •e. Must be between the ages of 17 and 65 years, inclusive
- •2. If on corticosteroids, anti-hypertensive medications, anti-proteinuric medications (e.g., ACE inhibitors or angiotensin receptor blockers [ARBs]), or mycophenolate mofetil (MMF), must be on a stable dose for at least 4 weeks prior to the first screening visit
- •3. Female participants of childbearing potential must agree to use an acceptable method of contraception (as defined in Section 5.5.5) from the date of signing the informed consent to the first day of dosing (Day 1), and must agree to use a highly effective form of contraception (as defined in Section 5.5.5) from the first day of dosing to 30 days after their last dose of study drug. Female participants of childbearing potential must also have a negative serum pregnancy test during Screening and negative urine pregnancy test on Day 1. Female participants of non-childbearing potential need not employ a method of contraception.
- •4. Non-sterile male participants must agree to use a highly effective form of contraception (as defined in Section 5.5.5) with their partner(s) of childbearing potential from the first day of dosing to 90 days after their last dose of study drug. Male participants who are surgically sterile need not employ additional contraception. Male participants must agree not to donate sperm while enrolled in this study and for up to 90 days after their last dose of study drug.
- •5. Must be capable of providing written informed consent, must be willing and able to comply with the requirements and restrictions listed in the consent form and with all procedures in the protocol
- •6. Must be up-to-date on routine vaccinations, or willing to be brought up-to-date, based on local guidelines
- •7. Must be willing to comply with study-specific vaccination requirements, including those for N. meningitidis, H. influenzae, and S. pneumoniae
- •8. Must be willing to have transportation and telephone access, and to
排除标准
- •1. Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant
- •2. Have a history or presence of any clinically relevant co-morbidities that would make the patient inappropriate for the study (for example, a comorbidity which is likely to result in deterioration of the patient’s condition, affect the patient’s safety during the study, or confound the results of the study), in the opinion of the PI
- •3. Have an estimated GFR <30 mL/min/1.73 m2 at the time of screening or at any time over the preceding four weeks
- •4. Have C4 levels <80% LLN at the time of screening (applicable only to participants who did not complete ACH471-201)
- •5. Is a renal transplant recipient or receiving renal replacement therapy
- •6. Have other renal diseases that would interfere with interpretation of the study
- •7. Have evidence of monoclonal gammopathy of unclear significance (MGUS), infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN may be secondary
- •8. Have been diagnosed with or show evidence of hepatobiliary cholestasis
- •9. Are known to have Gilbert’s syndrome and/or have a history suggestive of Gilbert’s syndrome
- •10. Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration or patients with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of ACH-0144471 administration
- •11. Have a history of febrile illness, a body temperature >38°C, or other evidence of a clinically significant active infection, within 14 days prior to ACH-0144471 administration
- •12. Have evidence of human immunodeficiency virus (HIV) (positive serology for HIV antibody [HIV Ab]), hepatitis B infection (positive hepatitis B surface antigen [HbsAg]), or hepatitis C infection (positive anti-HCV antibody [HCV Ab]) at Screening or historically
- •13. Have a history of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
- •14. Have a contraindication to one or more of the required vaccinations
- •15. Have a history of hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems, which, in the opinion of the investigator and/or an appropriately qualified immunology or infectious disease expert, would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- •16. Have participated in a clinical study in which an investigational drug was given within 30 days, or within 5 half-lives of the investigational drug, whichever is longer, prior to the first dose of ACH-0144471
- •17. Have received eculizumab at any dose or interval within the past 75 days prior to the first dose of ACH-0144471
- •18. Have received tacrolimus or cyclosporine within 2 weeks of the first dose of ACH-0144471
- •19. Have a 12-lead ECG with a QTcF >450 msec for males or >470 msec for females, or have ECG findings which, in the opinion of the PI, could put the patient at undue risk
- •20. Have received any drug known to prolong the QTc interval within 2 weeks of the first dose of ACH-0144471
- •21. Have any of the following laboratory abnormalities at screening:
- •Alanine transaminase (ALT) > upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) > ULN
- •Absolute neutrophil counts (ANC) <1,000/µL
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